Obstructive sleep apnea, which involves an interruption of normal breathing during sleep, is a very serious condition associated with numerous detrimental health effects. The most common type of sleep apnea is fundamentally caused by a relaxation of the human upper airway muscles during periods of sleep. Particularly, the majority of obstructive airway events are precipitated by the tongue and jaw sagging backwards when all of the muscles of the body relax with sleep. In a fair percentage of the population, approximately 10-15 percent, such relaxation closes the airway sufficiently to substantially and/or completely preclude breathing. In other instances, the airway is only partially occluded, causing the sleeping person to work harder during breathing to obtain sufficient oxygen. The characteristic noises of snoring result from air being forcefully drawn into and/or forced out through the airway past an obstruction.
Both snoring and sleep apnea cause oxygen levels to drop, and cause sleep to become highly fractionated. Among other things, intermittent oxygen deprivation can lead to damage to the heart and brain, resulting in an increased risk and/or incidence of heart attack and stroke. At a minimum, mild sleep apnea and snoring result in non-restorative sleep and daytime sleepiness, which can further lead to a host of dangers resulting from a lack of awareness and adequate reaction speed (e.g., motor vehicle accidents, industrial accidents). Long term adherence to therapy, however, has been shown to reduce the risk of heart attack, stroke, death, and alertness related events such as motor vehicle accidents. The three primary accepted treatments and/or therapies for sleep apnea and snoring include Continuous Positive Airway Pressure (CPAP), Mandibular Advancement Devices (e.g., oral appliances), and surgery.
CPAP therapy involves using a mask-like device that provides a gentle amount of counter air pressure: through a snugly fitting mask worn about the nose during sleep. The air pressure provided by the mask, often conceived of as a “pneumatic splint”, prevents the upper airway muscles from fully collapsing into the airway when relaxed. The device is highly effective, but due to a large number of disadvantages, adherence to CPAP therapy by patients can be as low as approximately 50 percent. Among the disadvantages are sometimes poorly fitting and/or leaking masks, claustrophobia experienced by some patients, awkwardness of the mask and tubing, and the noise produced by and space consumed by the typically nearby air compressor.
A mandibular advancement device functionally and structurally comprises a bite plate configured to hold the lower jaw (mandible) forward while one sleeps. This is particularly helpful for patients experiencing snoring and sleep apnea that occurs when sleeping supine (i.e., lying on their back and facing upward). However, long term use of a mandibular advancement device frequently causes jaw discomfort and migration of teeth in the jaw, both consequences of a constant force exerted upon the jaw for durations of up to 6-8 hours at a time (e.g., all night).
Surgical options for treating sleep apnea and snoring are numerous, but none provide a guaranteed cure except the drastic step of performing a tracheotomy. As substantial deterrents, surgeries are expensive, painful, and in the best of situations, provide cure rates of only approximately 50-70 percent. Further, surgery can lead to long-term complications such as altered swallowing, speech impairment, and scar tissue formation. In general, for patients having only mild sleep apnea and/or snoring, the awkwardness, discomfort, and risks of these three conventional forms of therapy frequently outweigh the potential benefits. Therefore, treatment in patients experiencing relatively mild symptoms is particularly problematic.